SVO70 (Optimal Target Low-Density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke): Rationale and Study Design.

backgroundCurrent stroke guidelines lack subtype-specific recommendations for optimal low-density lipoprotein cholesterol targets. Indeed, most lipid-lowering trials have not differentiated between stroke subtypes or focused primarily on large artery atherosclerosis, leaving a gap in evidence for other stroke subtypes, such as small vessel occlusion stroke. This study is designed to evaluate whether intensive lipid-lowering therapy is superior to standard therapy in reducing major adverse cardiovascular events among patients with small vessel occlusion stroke.

methodsSVO70 (Optimal Target Low-Density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke) is a multicenter, prospective, randomized, open, blinded-end point clinical trial in which adult patients with neuroimaging-confirmed small vessel occlusion stroke within 180 days of randomization will be enrolled. Key exclusion criteria include predefined low-density lipoprotein cholesterol targets for other comorbidities, contraindications to statin, and pregnancy or lactation. Eligible participants will be randomized 1:1 to achieve low-density lipoprotein cholesterol <70 mg/dL (intensive group) or 90 to 110 mg/dL (standard group). The trial aims to enroll 4016 participants over a 2-year recruitment period, with a minimum follow-up of 4 years. The primary end point is the occurrence of major adverse cardiovascular events, defined as cardiovascular death, stroke, and acute coronary syndrome, during the follow-up period. Secondary end points include (1) any stroke, (2) ischemic stroke or transient ischemic attack, (3) hemorrhagic stroke, (4) cardiovascular death, (5) myocardial infarction, (6) all-cause death, and (7) acute coronary syndrome.

conclusionsThis study will provide valuable information for determining optimal low-density lipoprotein cholesterol targets for patients with small vessel occlusion stroke. REGISTRATION: URL: https://ClinicalTrials.gov; Unique Identifier: NCT06649240, Clinical Research Information Service (KCT0009043).